Beckman Coulter Biomedical GmbH
DE-MF-000008041 · Germany · Munich
Beckman Coulter Biomedical GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: DxA 5000, DxA 5000 Fit, DxOne Workflow Manager.
Devices declared under this manufacturer
- DxA 5000, DxA 5000 Fit
- DxOne Workflow Manager
- Pipette Tips
- Secondary Round Bottom Tubes
- Secondary Tube Caps
- Universal Push Caps
Catalogue references include B24687, B87352, C11862, C27703, C48130, C48131.
European nomenclature codes declared: W02060185, W02060101, W02060182.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Beckman Coulter Biomedical GmbH (DE) · FDA 3006677029 |
| Devices in EUDAMED | 7 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 14.3 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Beckman Coulter Biomedical GmbH is registered in the United States but was not found in the Canadian register.